An interventional study of Education through a 3D model and Education through a traditional pedagogical support in Lumbar Spine Disease, sponsored by Université Paris-Sud. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Université Paris-Sud · Not applicable, Interventional, and Other
The goal of this clinical trial is to evaluate and compare the effectiveness of a 3D interactive model versus traditional teaching methods in enhancing the teaching of thoracic and lumbar spine fractures classification (AO Spine) among orthopedic residents.
The main questions this study aims to answer are:
Does the use of a 3D interactive model improve residents' knowledge regarding the AO Spine classification of spine fractures compared to traditional teaching methods? To what extent does the utilization of a 3D interactive model enhance understanding of spinal anatomy, injury mechanisms, pathophysiology, and fracture diagnosis among surgical residents?
Participants will be randomly assigned to either:
Group A: Access to the 3D interactive model depicting thoracic and lumbar spine fractures based on the AO Spine classification. They can explore fractures, access textual information, and anatomical annotations.
Group B: Traditional teaching materials including slides, texts, and diagrams illustrating spine fractures according to the AO Spine classification.
Researchers will compare the post-training knowledge and confidence levels in managing spine fractures between the two groups to assess the efficacy of the 3D model.
Participants will be required to fill out pre- and post-training questionnaires assessing their knowledge, experience with 3D educational tools, confidence levels in managing spine fractures, and satisfaction with the teaching method.
The study aims to ascertain if the use of the 3D model significantly enhances residents' comprehension of spine fractures compared to conventional teaching methods within the orthopedic curriculum.
Detailed Study Protocol
Primary Study - Validation of 3D Interactive Model for Teaching AO Spine Classification for Thoracic and Lumbar Spine Fractures
Introduction:
Thoracic and lumbar spinal fractures are common in orthopedic and trauma surgery. Despite various classifications available, such as the AO Spine classification, understanding these fractures, especially for novice residents, can be challenging. In response, a 3D interactive model has been developed to support the classification teaching. A preliminary validation study with expert surgeons has been conducted.
Objectives:
This study aims to validate the effectiveness of a 3D model in teaching thoracic and lumbar spine fractures compared to traditional teaching methods. The primary objective is to assess whether the use of the 3D model improves residents' knowledge regarding AO Spine classification, anatomy, injury mechanisms, pathophysiology, and diagnosis of spine fractures.
Methods:
This prospective randomized validation study will start in May 2024.
Two additional studies will be conducted as follows, with the same protocol :
174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 106 interventional studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →Université Paris-Sud is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Residents having access to the 3D model
Other: Education through a 3D model
Residents having access to traditional educational support
Other: Education through a traditional pedagogical support
Training through a 3D model of the spine fractures
Training through a traditional pedagogical support
Specific Questionnaire
The primary outcome measure will be the final score on the post-test questionnaire assessing the student's knowledge. Each of the three studies will have specific questionnaire.
Time frame: Immediately after the intervention
Objective Structured Assessment of Technical Skills (OSATS)
Assessment questionnaire of the students technical skills during the validation phase on sawbones. OSATS scale ranges from 7 to 35 points: the higher the score, the better the technical surgical skills.
Time frame: Immediately after the intervention
Subjective questionnaire
Final score on a subjective questionnaire evaluating ease of use, immersion and satisfaction with the simulator. Each item ranges from 1 to 10, 10 being the best score (easiest use of the simulator, best immersion, best satisfaction).
Time frame: Immediately after the intervention
No study locations are listed for this record.
Plan to share: Yes — IPD can be made available on reasonable request
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Université Paris-Sud